1. Field of the Invention
The present invention relates to a tissue securement system, device and method for endoscopy or endosonography-guided transluminal interventions whereby a ligation or anchor is placed and secured into soft tissue.
2. Background of the Invention
Gastroesophageal reflux disease (GERD) is a chronic condition caused by the failure of the anti-reflux barrier located at the gastroesophageal junction to keep the contents of the stomach from refluxing back into the esophagus.
Surgical fundoplication is the gold standard for anatomic correction of the cardia in patients with GERD. However this procedure can have a high incidence of postoperative complications and extended recovery times. Therefore endoscopic methods for enhancing the lower esophageal sphincter have been developed as an alternative to surgery. Endoscopic treatments of GERD target the esophageal and gastric wall in the region of the lower esophageal sphincter. Methods including suture plication, radiofrequency energy ablation, and implant insertion are employed to prevent reflux by mechanisms that include the creation of a mechanical barrier by narrowing the lumen, altering the esophago-gastric angle (angle of His or “flap valve”), and altering the lower esophageal sphincter to enhance its function or decrease transient lower esophageal sphincter relaxations. The endoscopic methods can be performed entirely through the endoscope placed transorally, avoiding any abdominal incisions.
Endoscopic treatment is often limited because the operator can only visualize the mucosal lining of the gastrointestinal wall that is located directly in front of the endoscope. Structures deep within the wall, and outside the wall, cannot be seen. The ability to visualize these structures may influence the proper placement of a treatment apparatus and may expand the therapeutic strategies. For example placement of a suture or ligating element through the esophageal and fundal walls that also includes placement through the diaphragmatic crura may be useful. The use of endoscopic ultrasonography may address this limitation. In this procedure a combination endoscope and ultrasound instrument called an echoendoscope is utilized. From the distal esophagus, pertinent structures visualized with the echoendoscope include the lower esophageal sphincter (LES) within the wall, the crural diaphragm, and the fundus of the stomach. The diaphragmatic crura are typically seen interposed between the distal esophageal wall and the fundus of the stomach. One aspect of this invention utilizes the visualization capabilities of ultrasound endoscopy to permit a novel device and method for treating GERD.